Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Asociación para Evitar la Ceguera en México |
---|---|
Information provided by: | Asociación para Evitar la Ceguera en México |
ClinicalTrials.gov Identifier: | NCT00347698 |
The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.
Condition | Intervention | Phase |
---|---|---|
Diabetic Retinopathy |
Drug: intravitreal injection of bevacizumab Procedure: panretinal photocoagulation |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2007 |
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerardo García-Aguirre, MD | +52 (55) 10841400 ext 1172 | retinamex@yahoo.com |
Contact: Elizabeth Reyna-Castelán, MD | +52 (55)10841400 ext 1172 | retinamex@yahoo.com |
Mexico, D. F | |
Asociación para Evitar la Ceguera en México | Recruiting |
Mexico City, D. F, Mexico, 04030 | |
Contact: Yoko Burgoa +52 (55) 1084 1400 ext 1171 retinamex@yahoo.com | |
Contact: Mariana Martinez, MD +52 (55) 1084 1400 ext 1171 retinamex@yahoo.com | |
Principal Investigator: Gerardo García-Aguirre, MD | |
Sub-Investigator: Hugo Quiroz-Mercado, MD | |
Sub-Investigator: Veronica Kon-Jara, MD | |
Sub-Investigator: Mitzy Torres, MD | |
Sub-Investigator: Elizabeth Reyna-Castelan, MD |
Principal Investigator: | Gerardo García-Aguirre, MD | Asociación para Evitar la Ceguera en México |
Study ID Numbers: | APEC-007 |
Study First Received: | June 30, 2006 |
Last Updated: | June 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00347698 |
Health Authority: | Mexico: Ethics Committee; Mexico: Ministry of Health |
diabetic retinopathy bevacizumab photocoagulation |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Bevacizumab Endocrinopathy Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs Cardiovascular Diseases |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |